Trial · NCT07905131
A Study of Perioperative Navlimetostat Combined With Modified FOLFIRINOX in Patients With MTAP-Deleted Pancreatic Cancer
NCT07905131, Phase 1, Phase 2, Not yet recruiting, Daniel Nussbaum, M.D.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Perioperative Navlimetostat Combined With Modified FOLFIRINOX in Patients With MTAP-Deleted Pancreatic Cancer. Trials, record NCT07905131. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07905131
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Perioperative Navlimetostat Combined With Modified FOLFIRINOX in Patients With MTAP-Deleted Pancreatic Cancer
- NCT number
- NCT07905131
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, estimated
- Lead sponsor
- Daniel Nussbaum, M.D.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Interventions
- Navlimetostat, mFOLFIRINOX Treatment Regimen
- First posted
- 2026-10-29
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events | Up to 15 months | Adverse events are assessed at every study visit and logged according to NCI-CTCAE v6.0. |
| Primary | Recommended phase 2 dose of navlimetostat, as measured by the number of participants who experience a dose limiting toxicity during the first cycle of the phase 1b portion of the study | Dose limiting toxicities are assessed throughout the first 28 days on combination treatment. | Dose limiting toxicities are assessed throughout the first 28 days on combination treatment and are logged according to NCI-CTCAE v6.0 |
| Primary | Feasibility of perioperative navlimetostat combined with mFOLFIRINOX | Measured from the start of study treatment with navlimetostat through 14 days after surgery. | Feasibility is measured by the proportion of evaluable participants who receive at least four doses of mFOLFIRINOX and at least one dose of navlimetostat prior to surgery, undergo surgical resection within 60 days of completing mFOLFIRINOX, and do not experience significant unexpected postoperative complications considered at least possibly related to navlimetostat within 14 days of surgery. |
| Primary | Severity of Adverse Events | Up to 15 months | Adverse events are assessed at every study visit and logged according to NCI-CTCAE v6.0. |
| Primary | Incidence of dose limiting toxicities | The first 28 days of combination treatment | Incidence of protocol-defined dose limiting toxicites, as assessed and graded per NCI-CTCAE v 6.0. |
| Secondary | Pathologic response rate | Measured within one week post-operatively | Pathologic response rate is measured by College of American Pathologists (CAP) score of patients who undergo surgery. CAP scores range from 0-3, where 0=Complete response and 3=Poor or no response. |
| Secondary | Recurrence free survival (RFS) | Up to three years | RFS is defined as the time from surgery to documented recurrence or death due to any cause. |
| Secondary | Overall survival (OS) | Up to three years | OS is defined as the time from the first dose of navlimetostat to death due to any cause. |
| Secondary | Event free survival (EFS) | Up to three years | EFS is defined as the time from the first dose of navlimetostat to clinical or radiographic progression, death due to any cause, or navlimetostat discontinuation due to toxicity |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07905131
GET https://conductscience.org/api/trials/v1/NCT07905131/registered